Announcement by the National Medical Products Administration on Reissuing the Fee Standards for Drug Registration (No. 75 of 2020)

　　Release date: 2020-06-30

　　In accordance with the “Administrative Measures for Drug Registration” (Order No. 27 of the State Administration for Market Regulation), the “Notice on Re-issuing the List of Administrative and Public Service Charges Managed by the Central Government’s Food and Drug Administration” (Cai Shui [2015] No. 2), and the “Notice on Issuing the ‘Administrative Measures for Fee Standards for Drug and Medical Device Product Registration’” (Fa Gai Jia Ge [2015] No. 1006), the National Medical Products Administration has formulated the “Fee Standards for Drug Registration” and the “Detailed Implementation Rules for Drug Registration Fees.” These are hereby promulgated and shall take effect as of July 1, 2020.

　　For drug registration applications accepted before July 1, 2020, if the required fee is not paid within 15 working days starting from July 1, the drug registration procedure will be terminated.

　　According to the “Announcement on Exempting Certain Administrative and Public Service Fees and Governmental Funds During the Prevention and Control of Pneumonia Caused by the Novel Coronavirus Infection” (Ministry of Finance, National Development and Reform Commission, No. 11 of 2020), during the prevention and control period of pneumonia caused by the novel coronavirus infection, the drug registration fee shall be waived for drugs that have entered the special approval procedure and are used for the treatment and prevention of pneumonia caused by the novel coronavirus infection.

　　In the event of any inconsistency between previous regulations and this notice, this notice shall prevail.

　　Hereby announced.

　　Attachment: 1. Drug Registration Fee Standards

　　2. Implementation Rules for Drug Registration Fees

　　National Medical Products Administration

　　June 30, 2020

　　Attachment 1

　　Drug Registration Fee Standards

　　The National Medical Products Administration and provincial-level drug regulatory authorities, in accordance with their statutory duties, carry out registration activities—including administrative acceptance, on-site inspections/verifications, and technical reviews—on applications for clinical trials of drugs, applications for marketing authorization, supplementary applications, and re-registration applications, and collect the relevant fees according to established standards. The specific fee schedule is as follows:

　　Note: 1. Drug registration fees are charged per active pharmaceutical ingredient or per dosage form as a single product. If an additional specification is added, the registration fee will be increased by 20% according to the corresponding category.

　　2. For application items classified as filing/reporting changes under the “Administrative Measures for Drug Registration” that fall under the purview of provincial drug regulatory authorities or the State Council’s drug regulatory authority, no registration fee shall be charged.

　　3. For applications to import pharmaceutical products (herbal medicines) in a single transaction, the drug registration fee shall be RMB 0.20 ten thousand yuan per product (herbal medicine).

　　4. The registration fee for pharmaceutical products manufactured overseas shall be increased by the difference in transportation, accommodation, and meal expenses incurred during on-site and off-site inspections, based on the corresponding domestic registration fee standards.

　　5. The fee standards for drug registration in Hong Kong, Macao, and Taiwan shall be the same as those for drug registration of products manufactured overseas.

　　6. The fee standards for expedited drug registration will be formulated separately.

　　Appendix 2

　　Implementation Rules for Drug Registration Fees

　　These Implementation Rules are formulated in accordance with relevant provisions, including the “Administrative Measures for Drug Registration,” the “Notice on Re-issuing the List of Administrative and Public Service Charges Managed by the Central Government’s Food and Drug Administration,” and the “Notice on Issuing the ‘Administrative Measures for Fee Standards for Drug and Medical Device Product Registration.’”

　　I. Procedure for Paying Drug Registration Fees

　　(1) New Drug Registration Application

　　The applicant for registration submits an application for clinical trials or marketing authorization of a drug to the Center for Drug Evaluation under the National Medical Products Administration. After acceptance by the Center for Drug Evaluation, the applicant will receive a “Notice of Payment for Administrative Licensing Items” (see attachment; the same applies hereinafter), and shall make the payment as required.

　　(2) Generic Drug Registration Application

　　The applicant submits an application to the Center for Drug Evaluation under the National Medical Products Administration. After acceptance, the Center for Drug Evaluation issues a “Notice of Payment for Administrative Licensing Items,” and the applicant makes the payment as required.

　　For generic drugs requiring clinical trials, the clinical registration fee is RMB 134,400 (for domestically produced drugs, the fee is RMB 318,000 minus RMB 183,600, equaling RMB 134,400; for foreign-produced drugs, the fee is RMB 502,000 minus RMB 367,600, also equaling RMB 134,400). After completion of clinical trials and submission of an application for marketing authorization, the fee will be charged according to the requirements for applications that do not require clinical trials: RMB 183,600 for domestically produced drugs and RMB 367,600 for foreign-produced drugs. If a generic drug directly applies for marketing authorization and independently obtains clinical data, the fee will be RMB 318,000 for domestically produced drugs and RMB 502,000 for foreign-produced drugs. For drugs exempt from clinical trials, the fee is RMB 183,600 for domestically produced drugs and RMB 367,600 for foreign-produced drugs.

　　(3) Supplementary Application for Registration

　　The applicant submits a supplementary application for approval to the Drug Review Center of the National Medical Products Administration. After acceptance by the Drug Review Center, the center will issue a “Notice of Payment for Administrative Licensing Items,” and the applicant shall make the payment as required.

　　(4) Re-registration Application for Pharmaceuticals Manufactured Overseas

　　The applicant submits an application to the Center for Drug Evaluation under the National Medical Products Administration. After acceptance, the Center for Drug Evaluation issues a “Notice of Payment for Administrative Licensing Items,” and the applicant makes the payment as required.

　　II. Instructions for Payment of Drug Registration Fees

　　(1) According to the “Classification of Chemical Drug Registration and Requirements for Submission of Application Materials,” chemical drugs classified as Category 1 and Category 2 shall pay registration fees based on the standards for new drug registration, while those classified as Category 3, Category 4, and Category 5 shall pay fees according to the standards for generic drug registration. Under the “Classification of Biological Product Registration and Requirements for Submission of Application Materials,” all categories of biological products shall pay registration fees based on the standards for new drug registration. According to the “Classification of Traditional Chinese Medicine (TCM) Registration and Requirements for Submission of Application Materials,” innovative TCMs and improved new TCMs shall pay registration fees based on the standards for new drug registration, whereas compound preparations of TCM derived from ancient classic prescriptions, drugs with the same name and formula, and other categories shall pay fees according to the standards for generic drug registration.

　　(2) Supplementary applications (requiring technical review) refer to those supplementary application items that require technical review.

　　(3) Supplementary applications (not requiring technical review) refer to applications for the use of trade names and other matters specified by the National Medical Products Administration that require approval but do not necessitate technical review.

　　(4) Within 15 working days after the acceptance of the drug registration application, the applicant shall pay the registration fee as required. The date on which the National Medical Products Administration receives the remittance shall be deemed as the date of payment by the applicant. Failure to pay as required will result in the termination of the drug registration review and approval process.

　　III. Payment for Chemical Active Pharmaceutical Ingredients

　　(1) Application for Registration of Chemical Active Pharmaceutical Ingredients

　　Chemical APIs used in the manufacture of domestically marketed drugs that have already been approved for listing shall be registered on the Excipient and Packaging Materials Platform.

　　Pay the fee according to the fee standards for generic drug marketing authorization applications: RMB 183,600 for chemically synthesized active pharmaceutical ingredients manufactured domestically, and RMB 367,600 for applications for marketing authorization of chemically synthesized active pharmaceutical ingredients manufactured overseas. If submitted together with the finished dosage form, payment should be made under the corresponding acceptance number for the finished dosage form.

　　When other chemical active pharmaceutical ingredients apply for market approval, the fee shall be 50% of the corresponding fee standard.

　　During the clinical trial application stage, the application is submitted together with the formulation; only the approval conclusion for the formulation will be issued, and no fee will be charged. During the marketing authorization application stage, for chemical APIs manufactured domestically that are registered on the excipient and packaging materials platform or submitted together with the formulation, the fee is RMB 216,000. For chemical APIs manufactured overseas, the fee is RMB 296,950. If the API is submitted together with the formulation, payment should be made under the acceptance number corresponding to the formulation.

　　The chemical active pharmaceutical ingredients used in generic drugs are those that have not been used in domestically marketed formulations; fees shall be paid based on the chemical active pharmaceutical ingredients used in the domestically marketed drugs being imitated.

　　(2) Supplementary Application for Chemical Active Pharmaceutical Ingredients

　　For supplementary applications for chemical active pharmaceutical ingredients, if the application is registered on the Excipient and Packaging Materials Platform or submitted together with the finished dosage form, the fee shall be paid according to the fee standards applicable to technical reviews. If the application is submitted together with the finished dosage form, payment shall be made under the acceptance number of the corresponding finished dosage form. No fee is required for changes classified as filing or reporting.

　　IV. Fee Reduction and Preferential Policies for Small and Micro Enterprises

　　(1) Scope of Benefits

　　Innovative drug registration applications submitted by small and micro enterprises that meet the criteria stipulated by the State Council shall be exempt from the new drug registration fee.

　　1. Effective ingredients extracted from plants, animals, minerals, and other substances, as well as traditional Chinese medicines containing such ingredients, for the treatment of AIDS and malignant tumors that have not yet been marketed in China.

　　2. Chemical APIs and their formulations that are produced via synthetic or semi-synthetic methods and have not been marketed either domestically or internationally.

　　3. Category 1 registration for therapeutic biological products and Category 1 registration for preventive biological products.

　　In addition, for innovative drugs that meet the requirements set forth by the State Council and have already been exempted from clinical trial registration fees as per regulations, supplementary applications submitted during the clinical trial period will also be exempt from registration fees.

　　(2) Required Documents to Be Submitted

　　For registered applicants who meet the criteria specified in the “Regulations on the Classification Standards for Small and Medium-sized Enterprises” (MIIT Joint Enterprise [2011] No. 300), when applying for preferential fee policies for small and micro enterprises, please submit the following materials to the collecting agency:

　　1. Application Form for Fee Reduction and Exemption for Small and Micro Enterprises (see Appendix);

　　2. A copy of the business license of the enterprise;

　　3. The enterprise income tax return for the previous year (must be stamped and confirmed by the tax authority) or the valid statistical report for the previous year (issued by the statistics authority).

　　In addition, when filling out the registration application form for domestically produced pharmaceuticals, simply select the corresponding category.

　　(3) Recognition Criteria and Supervision

　　Non-manufacturing enterprises are classified as small and micro enterprises according to the “Other Unlisted Industries” category specified in the “Regulations on the Classification Standards for Small and Medium-sized Enterprises” (MIIT Joint Enterprise [2011] No. 300). Manufacturing enterprises are classified as small and micro enterprises under the “Industrial” category. To submit a clinical or marketing registration application, both the applicant and the manufacturing enterprise must simultaneously meet the eligibility criteria for small and micro enterprises.

　　Applications from small and micro enterprises must be submitted simultaneously with the registration application. Once the application is accepted, no further applications from small and micro enterprises will be processed. Applicants should pay the corresponding registration fees.

　　V. Other Clarifications on Issues

　　(1) Issue of retroactive fee payments. If retroactive fee payments are involved, such payments shall be made in accordance with the procedures stipulated by the National Medical Products Administration.

　　(2) Refund Issues. If the refund is requested due to an erroneous remittance caused by the applicant, the applicant shall submit a refund application, remittance receipt, and the “General Payment Notice for Non-Tax Revenue” (receipt) along with other relevant materials to the Administrative Affairs Acceptance Service and Complaint & Reporting Center of the National Medical Products Administration. If the refund is not due to an error on the part of the applicant, the Drug Registration Management Division of the National Medical Products Administration will issue a refund notice to the Administrative Affairs Acceptance Service and Complaint & Reporting Center of the National Medical Products Administration. The Administrative Affairs Acceptance Service and Complaint & Reporting Center will then contact the registrant, who will submit a refund application, remittance receipt, and the “General Payment Notice for Non-Tax Revenue” (receipt) along with other required documents. Refund procedures shall be completed according to regulations before the end of April or October each year. If the applicant voluntarily withdraws the registration application after it has been accepted, or if the National Medical Products Administration makes a decision not to grant approval in accordance with the law, the registration fee already paid will not be refunded. Should the applicant re-submit a registration application, the fee must be paid again.

　　(3) Combination products of pharmaceuticals and medical devices. For combination products of pharmaceuticals and medical devices, the registration fee shall be charged based on the substance that plays the primary role.

　　Attachment: 1. Application Form for Fee Reductions for Small and Micro Enterprises

　　2. Notice of Payment for Administrative Licensing Projects of the National Medical Products Administration

　　Appendix 1

　　Application Form for Fee Reductions for Small and Micro Enterprises

Appendix 2

　　National Medical Products Administration

　　Notice of Payment for Administrative Licensing Project

　　Application Number:

　　Application item:

　　Project Name:

　　Applying Organization and Contact Address:

　　Domestic agency and contact address:

　　Amount due: RMB per formulation + RMB for active pharmaceutical ingredient = RMB

　　Paying entity and contact address:

　　Contact Person: Contact Phone: Mobile: Postal Code:

　　The above-mentioned license application has been accepted. The paying entity shall, within 15 working days after the drug registration application is accepted, pay the registration fee as required. The date on which the applicant makes the payment shall be determined by the date the National Medical Products Administration receives the remittance. Failure to pay the fee as required will result in the termination of the drug registration review and approval process.

　　Payee: National Medical Products Administration

　　Beneficiary: National Medical Products Administration

　　Opening Bank: CITIC Bank Beijing Jiaotong University Branch

　　Bank Name: CITIC BANK JIAODA SUB-BRANCH, SWIFT Code: CIBKCNBJ100

　　Bank account number: 7112010189800000260

　　When making a remittance, be sure to indicate the acceptance number.

　　After confirming that the required fees have been received, the Administrative Affairs Acceptance Service and Complaint & Reporting Center of the National Medical Products Administration will mail the payment receipt to the paying entity within 20 working days.

　　Payment Notes:

　　1. The payment for the above-mentioned fees shall be made directly by the paying entity designated in this notice; no other entity may make the payment on its behalf. Otherwise, the fees due for the requested matter will be deemed as unpaid.

　　2. The fee payable for each application must be remitted in a single payment, and the exact amount specified as due must be paid precisely. If there are multiple application items, payments should be made separately for each item; otherwise, the fees payable for the unremitted application items will be deemed not received.

　　3. Applicants must, within the prescribed payment deadline, make bank transfers directly from their bank account to the bank and account number indicated in this notice. To ensure timely receipt of payments for each application, please be sure to include the application acceptance number on the remittance slip. Failure to indicate the acceptance number may delay the review and approval process of your application.

　　4. In accordance with national regulations, all administrative fees related to approval procedures must be paid directly by the applicant into the state treasury. Therefore, applicants are strongly advised to keep their payment receipts carefully. You can check the status of your payment online (www.nmpa.gov.cn) five business days after making the remittance. If you have not received your payment receipt within one month, please promptly check the status online or contact the Administrative Affairs Acceptance and Complaints & Reporting Center of the National Medical Products Administration at 010-88331734 or 1735.

　　5. After making the remittance, please be sure to fax the remittance receipt, clearly indicating the acceptance number, to 010-88331733 on the same day. Also, confirm by phone with the Administrative Affairs Acceptance Service and Complaint & Reporting Center of the National Medical Products Administration to avoid any delay in the review and approval process.

　　Distribution: National Development and Reform Commission, Ministry of Finance.

　　Issued by the Comprehensive and Planning Finance Department of the National Medical Products Administration on June 30, 2020